The Associate Director of Commissioning, Qualification, and Validation (CQV) is responsible for leading and executing CQV activities for a large-scale biologics manufacturing facility in compliance with regulatory requirements, including 21 CFR Parts 11, 210, and 211, as well as ASTM E2500 guidelines. This role ensures that all facility, utility, equipment, and process qualification activities are conducted efficiently and in alignment with Good Engineering Practices (GEP) and Risk-based Validation approach. This role exists to guarantee the integrity and compliance of production systems and to mitigate risks associated with the therapeutic product lifecycle. The Associate...

The Quality Assurance (QA) Analyst II, under general direction, will be responsible for review and/or approval of basic and technical documentation; Drafting and reviewing of internal Quality policies and procedures; Assisting in and performing product related activities; Assisting in and performing Quality audit functions; Identifying process and Quality System improvements; Acting as a QA liaison internally.  

The Client Coordinator Administrative Assistant will provide comprehensive assistance and support to the program management team as well as facilitating client-facing site visits and coordinating internal and external events. This role is key to ensuring smooth operations and exceptional client interactions while supporting client-facing teams in significant matters requiring their attention.

The Senior Investigator of Deviations Management for Drug Product Finished Goods (DPFG) is responsible to complete major and complex manufacturing investigations, identify root cause, and create effective corrective and preventive actions (CAPAs). This role engages with regulatory inspectors, internal auditors, and senior leadership, as needed regarding the findings of investigations. Additionally, this role mentors and provides guidance to junior investigators throughout the investigation process.

A proactive and driven team player is required to passionately support delivery and embedding of the Data Integrity projects at FDBT. The Quality Assurance (QA) Specialist II for Data Integrity will be responsible for the day to day running of the FDBT Data Integrity Program, performing data integrity assessments, gap confirmation and risk assessments, generate remediation plans and categorize gaps based on business priority and risks.  

Summary:Fujifilm Diosynth Biotechnologies, Texas, Inc. is offering exciting summer internships for college students who have completed at least their sophomore year. We provide a...

FUJIFILM Electronic Materials, U.S.A., Inc., is a global leader in chemical solutions which enable the semiconductor industry and the digital universe. We have an exciting opportunity at our Pueblo, CO facility for a Cost Accountant!   With state-of-the-art manufacturing facilities in the U.S., Europe, Taiwan, China, Korea and Japan, local sales offices throughout the world and on-site applications support, FUJIFILM...

The Warehouse Associate 1 position is responsible for storage, handling, and distribution of materials and products. This role supports Warehouse operations in receiving, shipping, and/or logistics. The Warehouse Associate 1 works with multiple functions to support operations (e.g., Manufacturing, Quality, Process Sciences, and other customers). This role uses SAP ERP system for inventory management, cycle counting, and shipping activities while operating in a GMP facility with standard operating procedures (SOPs). This role requires shift work and/or weekend hours to support operations and is

This role will perform manufacturing support activities to ensure compliant and reliable production. This manufacturing facility is 24/7 operational and the role may require to be flexible with working hours. 

Fujifilm Sonosite’s goal is to launch the easiest to use point-of-care ultrasound (POCUS) solutions that have a reputation for reliability, while also meeting the objective of the broader business.  This role is vitally important in leading a team of product managers to advocate for our customers and ensure our product strategy comes to life.  To be successful in this role, the Sr Manager of Product Management has to be passionate about bringing products to market that delight customers and satisfy the reputation that Fujifilm Sonosite has always had around reliability, durability and ease of use while also living out all of our core values.

Summary:   Fujifilm Diosynth Biotechnologies Texas (FDBT) is seeking an eQMS Manager to lead the configuration, implementation, analysis, and maintenance of the electronic Quality Management Systems (eQMS). This role ensures compliance with cGMP, and regulatory requirements while optimizing eQMS functionality and efficiency. The ideal candidate will have strong leadership skills, technical expertise in eQMS systems, and experience with...

Summary:Fujifilm Diosynth Biotechnologies, Texas, Inc. is offering exciting summer internships for college students who have completed at least their sophomore year. We provide a...

Being a Product Manager at Fujifilm Sonosite, Inc. means you are an instrumental part of a passionate cross-functional development team that promotes growth and brand visibility. In this role, you will be responsible for driving the development and execution of marketing-related products and features.    The Product Manager is a resource for the Global Sales and Outbound Marketing Organizations and must be able to transform the customer’s business...

Summary:   The Quality Assurance Regulatory Affairs Supervisor is responsible for supporting the electronic publishing of regulatory submissions for national and regional regulatory agencies, and FUJIFILM Diosynth partner companies. The primary focus of this position is on moderate to complex regulatory submissions in both eCTD and non-eCTD format. Actual work assignments are based on the FUJIFILM Diosynth portfolio of work along with the incumbent's experience, knowledge, demonstrated technical skills, and...

Who We Are   FUJIFILM Electronic Materials, U.S.A., Inc., is a global leader in chemical solutions which enable the semiconductor industry and the digital universe. We have an exciting opportunity at our Pueblo, CO facility for an Operations Technician!   With state-of-the-art...

  Summary: The QC Stability Coordinator I, will construct, maintain, and oversee the Quality Control Testing of Stability programs to include developing a schedule of pull dates, overseeing testing of each pull, and generating summaries from the data. The Quality Control Coordinator I, under general direction, will be responsible for implementing a Quality Control Stability Program that will encompass the needs of the client for...

Summary: Fujifilm Diosynth Biotechnologies Texas (FDBT) is seeking Quality Assurance (QA) Validation - Associate Director to oversee the review and approval of commissioning, qualification, and validation protocols, reports, and discrepancies. This role will ensure compliance with FUJIFILM Diosynth Biotechnologies’ quality policies, site SOPs, and regulatory requirements while providing strategic leadership to the validation team.  

The Senior Program Manager is responsible for leading the planning, coordination, and execution of product development projects that result in new products or feature additions or enhancements to existing products. Acts as lead with Marketing, Engineering, Operations, Sales, as well as Service to establish and manage project plans to meet commitments and company objectives.  Facilitates the resolution of conflicts in the areas of product definition, project strategy and resource deployment. Ensures compliance with established procedures for product development in a regulated environment. ...

As a Clinical Engineer, you will use your ultrasound expertise and skills to identify, document, design, develop, and test point-of-care ultrasound systems, imaging, and features. You will use your knowledge, curiosity, and industry best practices to ensure Fujifilm Sonosite products are clinically diagnostic, safe, and meet user needs as you actively participate in a range of research and development activities. You will conduct extensive research and gather key data points to define clinical workflows, guide requirement development and designs, and inform current and future product development.  

We are seeking a highly skilled and experienced Quality Assurance Coordinator who will be responsible for leading material inspections and partnering with cross functional groups to achieve the resolution of quality issues within the business. The Quality Assurance Coordinator will lead Receiving and Inspection activities to ensure that inbound material meets all mechanical, electrical, and cosmetic specifications as identified in the quality inspection plan. They will support Supplier Quality Engineering with investigations associated with the Nonconformance Report process and the Materials Review Board. They will also champion activities within Materials Management,...